Job Listing
Science Policy Analyst
Food and Drug Administration · Posted 60 days ago
About the Role
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band C $121,785 - $169,583.
What You'll Do
- →Monitors and coordinates the development and implementation of guidance, workshops, research projects, grants, and stakeholder engagement designed to facilitate, support, and accelerate the development of drugs and therapeutic biologics.
- →Provides scientific expertise in the development of policies, procedures, and activities to ensure consistency in the application of biomarkers in regulatory decision-making and new drug application reviews.
- →Reviews submissions to the Drug Development Tool (DDT) Qualification Programs.
- →Reviews submissions to the biomarker qualification and Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot programs for drug development tools seeking qualification.
- →Provides relevant input to review divisions on questions of biomarker validation and standards of evidence by utilizing knowledge related to the regulatory review processes.
- →Provides recommendations regarding reviewability of biomarker submissions and suggests which disciplines should be consulted to review biomarker submissions.
- →Evaluates how measurement of the biomarkerin clinical trials can aid in selecting patients for clinical trials and evaluate if patients respond to and/or benefit from.
- →Participates in designing, developing, and implementing programs to facilitate the education of stakeholders on the use of biomarkers in drug development.
- →Assists in maintaining professional relationships with external stakeholders under supervisory oversight.
Requirements
- ✓Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required.
- ✓Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
- ✓TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements.
- ✓You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
- ✓Education must be accredited by an accrediting institution recognized by the U.S.
- ✓Department of Education in order for it to be credited towards qualifications.
- ✓Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S.
- ✓Department of Education.
- ✓If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.
- ✓Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file.
- ✓Therefore, you should consider asking the institution to provide the file in a non-secured electronic format.
- ✓Alternatively, you could scan or take a photo of the printed copy of the transcript.
- ✓If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
- ✓For further information, visit the U.S.
Personality Fit
Job ID: 11f601f0-d38f-4eef-b02b-77d5448cf1c3
Posted via USAJobs